Device Dossier

SenSight™ Burr Hole Device Model B31000 - Cranofacial fixation plate, non-biodegradable

Device Dossier for SenSight™ Burr Hole Device Model B31000 - Cranofacial fixation plate, non-biodegradable (Cranofacial fixation plate,…

Intended purpose

The Medtronic Model B31000 SenSight™ burr hole device is used as a component of a neurostimulation system for deep brain stimulation (DBS). The burr hole device is an implanted device intended to cover a 14-mm burr hole on the skull, and anchor a single compatible lead following cranial surgery.

Functional description

The Medtronic Models B31000 SenSight™ Burr Hole device is used with a neurostimulation system for deep brain stimulation (DBS). The device comprises 1 Burr Hole device, 1 Base, 1 Centering tool (preattached to the base),2 Bone screws (preinserted in the legs of the centering tool), 1 Support clip, 1 Cover.

TGA Public Summary